Bristol Myers Squibb Announces Commercial Launch of MS Drug

Bristol Myers Squibb recently announced that Zeposia (ozanimod) 0.92 mg for the treatment of relapsing multiple sclerosis (MS) is now commercially available in the US. 

Ozanimod, developed by Celgene, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that provides treatment for patients with no genetic test and no label-based first-dose observation required for patients. Bristol Myers Squibb acquired Celgene last year.

The medication is used for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

Multiple sclerosis a disease where the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell, Bristol Myers Squibb stated. 

Occasionally, the signal breakdown may lead to relapses. Ozanimod blocks the capacity of lymphocytes to escape from the lymph nodes, which reduces the number of lymphocytes in the blood.

“We are pleased to now bring ZEPOSIA, an important new once daily treatment option, to RMS patients,” said Tina Deignan, vice president and US head of immunology at Bristol Myers Squibb. 

“ZEPOSIA is the first and only S1P that requires no first dose observation, which may minimize the number of interactions RMS patients need to have with healthcare practitioners prior to initiating therapy during this unprecedented time of social distancing.”

Before initiation of treatment with ozanimod, all patients will require assessments, such as a recent complete blood count including a lymphocyte count within six months or after discontinuation of prior MS therapy, the company said.

Patients will also require an ECG to determine whether preexisting conduction abnormalities are present, a recent liver function test, and consideration of current and prior medications. This includes any vaccinations. 

An assessment of patients with a history of uveitis or macular edema, an ophthalmic assessment is also required.

Experts explained that patients who experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure in the last six months should not take ozanimod. 

Additionally, individuals who have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, sleep apnea, or those taking a monoamine oxidase inhibitor, should avoid the drug as well. 

Ozanimod may also increase risk of infections, bradyarrhythmia and atrioventricular conduction delays, liver injury, fetal risk, increased blood pressure, respiratory effects, macular edema, among other issues. 

Bristol Myers mentioned its program, Zeposia 360 support, to enhance access to the drug for MS patients.

“This includes a co-pay of as little as $0 for eligible appropriate patients, assistance with financial support, reimbursement for some initial out-of-pocket medical costs – and a program that may help eligible patients with commercial insurance to receive free medication while they are waiting for insurance approvals,” the company said. 

In February 2018, Celgene announced that it received a refusal to file letter from FDA regarding ozanimod. The agency determined that the nonclinical and clinical pharmacology sections in the non-disclosure agreement (NDA) were “insufficient” to permit a complete review.

But last year, Bristol-Myers acquired Celgene in a $74 billion merger deal. The company had its eyes on several of Celgene’s drugs in development, including ozanimod, which then carried the brand name, Zeposia. 

At the end of March, FDA approved ozanimod. This approval solidified the Bristol Myers-Celgene merger. 

“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” Jay Backstrom, MD, chief medical officer for Celgene, said in the announcement. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”